MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES STEALTH® CLAMPS; CLAMP, VASCULAR

Model Number	A3216
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: na.Event description: pcf information: these are mad vascular clamps.Please replace 3 units of clamp reference a3214 and 3 units of clamp reference a3216.Additional information received by applied medical rep via email on (b)(6) 2026: i didn't understand the problem either.Actually, there are only two defective units (1 ref 3214 and 1 ref 3216).They want more units to have more available in the operating room.Information received on (b)(6) 2026 via email by customer: two a3214 clamps were just brought back to me today.So now i have 3 a3214s and 1 a3216 that aren't working.That explains why we asked you for three.Additional information received by applied medical rep via email on 28apr26: they are bent or don't work.Additional information received by applied medical rep via email on 29apr26: the problem is that the clamps do not open and close easily, the closing clans are no longer opposite each other.Additional information received by applied medical rep via email on 6may26: the jaws have difficulty closing completely to lock the clip onto the vessel.Difficulty to open the device after attaching the clip on the vessel.Intervention: na.Patient status: na (before use).
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.

• Brand Name: STEALTH® CLAMPS
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 25211027
• Report Number: 2027111-2026-00567
• Device Sequence Number: 10403154
• Product Code: DXC
• UDI-Device Identifier: 00607915112769
• UDI-Public: (01)00607915112769
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K950492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A3216
• Device Catalogue Number: 100514301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/18/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown